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Sr. Technician, Facilities

Cambridge, MARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/301058

Job Title:  Sr. Technician, Facilities


Job Summary

  • Based at our new GMP Manufacturing facility in Norwood, MA, reporting to the Senior Director, Facilities & Engineering, this position will be responsible for maintenance and repairs of GMP/non-GMP process and support equipment.
  • This position will also support troubleshooting, investigations and reliability engineering for GMP/non-GMP process and support equipment.  
  • This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers.

Job Responsibilities

  • Perform preventative and corrective maintenance activities including simple calibrations as directed by schedule on all process equipment and systems, with established procedures and/or approved practices.  Lead efforts in developing remediation for follow-up and emergency work.
  • Troubleshooting on equipment and systems, including development of remediation activities for issues with multiple systems and equipment and repair malfunctioning equipment.  Work with equipment owners/engineers and direct the performance of work by equipment vendors.
  • Maintain cGMP records, both paper based and electronic.
  • Understand Asset Management and routine reliability concepts
  • Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as autoclaves, washers, TFF, Chromatography Columns and skids, mixers and stainless tanks.
  • Maintain Facilities SOPs as required.  Perform revisions and maintain author/owner responsibilities.
  • Lead performance of maintenance activities and small projects.
  • Provide “on-call” support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.
  • Maintain Qualified Trainer qualifications on OJTs assigned.  Develop OJT records.
  • Support and own Change Controls, CAPAs and Deviations
  • Ensure that spare parts, tools and equipment are available to complete all assigned tasks
  • Respond to alarms and document activities. Working with equipment owners, develop remediation activities for alarms. 
  • Manage contract service providers; including scheduling, training on required SOP’s, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.
  • Administer and perform hazardous energy control procedures and confined space entry  
  • Other duties as required

Education & Qualifications

  • At least 5 years relevant experience working in a regulated (cGMP preferred) environment.  Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.
  • Post-secondary degree in a science/technical field or a technical trade school degree.
  • Military training equivalent of above is acceptable.
  • Experience with Metrology preferred.
  • Understanding of PLC controls for simple troubleshooting is required.
  • Excellent interpersonal and communication skills (verbal and written) are required.  Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.  Technical writing skills required.
  • Must have a customer service mindset.
  • Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions.  Must be able to find true root cause and path forward for complex problems. 
  • Demonstrated ability to learn new equipment/systems.
  • Familiarity with Excel, Word, and PowerPoint are required.
  • Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.  Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.       
  • Ability to represent the company's interests, objectives and policies in a professional and responsible manner.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


Chat with me now! - https://flashrecruit.com/jobs/301058